Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
The Director of Analytical Development is responsible for leading the development, validation, implementation, and technology transfer of analytical test methods to support advancement of the pre-clinical and clinical development pipeline of small molecules from candidate nomination to marketing authorization. Key responsibilities are to drive strategic decisions to identify and implement those tests needed to fully characterize the physical and chemical properties of pharmaceutical materials (Drug Substances, Drug Products, Excipents, Key Intermediates, etc.). By providing methods, data, and subject matter expertise, the Director and his/her staff enable and serve as a key partner in Drug Substance and Drug Product development, manufacturing process development, stability evaluation, packaging material design and selection, and the identification of appropriate storage conditions and expiry dating. The Director manages the work within his/her group and external service providers to ensure that the goals of the project teams are met in a timely, cost-sensitive, and phase-appropriate fashion. The incumbent is responsible to develop and align analytical development activities with project teams, registrational and clinical development strategies and timelines and build the technical capabilities and collaborative scientific and operational partnerships needed to effectively carry out the department mission in a R&D/GMP/or GLP compliant quality standard as warranted.
Responsibilities include, but are not limited to, the following:
1. Science: The Director is responsible for leading the overall scientific, technical and operational efforts of a department within Analytical Development with delivery of physico-chemical characterizations and analytical methods, timely data, and process knowledge needed to meet Celgene project milestones and associated regulatory and international requirements. This includes the design of protocols, execution, reporting and approval of characterization, validation and qualification reports that support development activities.
2. Quality and Regulatory Standards: Develops and implements quality standards and specifications for drug substance and drug products under development and reviews and ensures the delivery of high quality-related sections in CMC sections of IND/CTA/NDA filings for Celgene NCEs. Addresses quality-related inquiries from regulatory agencies to support clinical trial and commercial marketing applications.
3. Compliance Systems: Sets a high compliance standard and ensures that systems and resources are in place to ensure the activities of the laboratories are conducted in compliance with cGMP/GLPs (as needed), SOPs, good documentation practices, DEA regulations and OSHA safety standards and in accordance with corporate requirements. Ensures overall laboratory readiness for regulatory inspections (FDA and DEA) and internal audits.
4. Manages Projects and teamwork: Responsible for quality, quantity and timelines for analytical projects and bringing analytical representation and expertise to CMC and project teams and task forces as appropriate. Facilitates teamwork and coordinates execution of plans with key stakeholders. Allocates resources and ensures tracking and follow-up as necessary. Ensures the department works as a development partner with collaborators and teams and facilitates the interpretation of data and the development of process knowledge to contribute to team and company goals.
5. Human Resources: Responsible for setting high standards, building and managing a high performing group. Diagnoses and defines strategies for effective performance. Sets department goals and performance objectives, supports personnel development and addresses performance issues. Identifies department needs and recruits/hires/promotes personnel as appropriate. Develops internal talent through coaching, training and other relevant experiences that meet the needs of the organization. Allocates proper resources for meeting goals and objectives. Shares responsibility for the department budget, including external contract testing expenses, capital and personnel requirements. Develops quality performance metrics to guide resource allocation, productivity of operations and continuous improvement.
6. Communications: Maintains productive communications with staff, Pharmaceutical Development colleagues, Quality Assurance, Technical Operations, and CMC Regulatory Affairs as needed to ensure understanding of needs, proper prioritization and the timely delivery of product knowledge, customer-oriented data and documentation. Regularly exchanges ideas and information to develop effective plans and strategies to meet business needs. Establishes effective partnerships/relationships through collaboration, expertise in current and future analytical technologies, and seamless transfer of information. Understands needs and considers external customers and/or internal clients in decisions and actions. Encourages and supports collaboration across departments and takes actions that are best for Celgene.
• Creates an impactful vision for the analytical function and communicates a supporting strategy to align people, resources and management within their department, cross-functionally, and at CROs or other partner organizations as needed.
• Delivers results with the proper blend of scientific rigor, development phase-appropriateness, and business acumen. Strives for continuous improvement.
• Sets high performance expectations and holds others accountable for the results expected.
• Sets high standards for talent acquisition and development for the department. Key participant in the hiring, development, and performance management of analytical staff.
• Encourages new ideas and processes, and encourages new approaches.
• Serves as a delegate for selected review/approval and management responsibilities for the Executive Director, as needed.
• Promotes a culture of technical excellence, multidisciplinary problem solving, teamwork, consistency, flexibility, execution, quality and effective communication.
• Influences and impacts others through building and maintaining strong networks that are leveraged to obtain critical information and accomplish objectives.
• Anticipates needs, assesses and manages risks and organizational dynamics as well as their implications.
• Expert at strategic planning, including the building of various options to meet AD project goals that achieve different balances of speed, cost, and risk. Able to envision, articulate, and deliver on a scenario that achieves the balance required by the project team.
• Recognizes and resolves broad based complex issues across organizational boundaries.
? PhD/MS in Analytical Chemistry or relevant scientific discipline
? 10+ years experience within analytical development function in pharmaceutical industry
? Scientific knowledge and experience in analytical/organic chemistry in drug development and associated analytical requirements throughout the discovery/development/commercial continuum. Maintains current awareness in areas of expertise.
? Excellent leadership, managerial and problem-solving skills
? Thorough knowledge of cGMP/GLPs in the pharmaceutical industry
? Thorough understanding of the regulatory requirements in CMC development
• Excellent written and communication skills to effectively represent the analytical issues with internal project and CMC teams, external contract organizations and senior management.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.